Hello!

To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might be necessary to respond to safety issues, market demand, or FDA requirements ECOs are documents that a company uses to track product changes. I currently work in a medical device technology company, but I have not needed an ECO yet. In product development, an ECO is needed if the following changes occur: a change in the method of manufacturing, a change in the material due to a change in retailer or material shortage, a change in the customer needs causing the redesign of a part of the product, updates to documents, changes to an SOP, or improvement of a design error.